inforamtion on CE marked medical devices and approvals

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

What type of information does the MHRA hold regarding ongoing or past approvals under the CE mark process for medical devices under EU regulations?.

I would like to know what type of (meta) data-set about approvals is collected, and held by the MHRA about each application or approval, or the whole set of past approvals.

I would like to know what types of information about ‘CE marked medical devices’ used in the UK, related to the CE mark process, and information provided by the companies that submit their products for certification under this approval system, are held by the MHRA.

For example, do they have access to any information about the contents of the application, the nature of the performance of the product (compared to other types or the general/generic type of product eg for comparison), or the decisions made based on that information, and so on. This would include any supporting data about device accuracy, or product performance in situ, prior to, or following CE mark approval.

Yours faithfully,
kate bloor

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 12/228

Dear Enquirer,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 11 June 2012.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
External Relations
Medicines and Healthcare products Regulatory Agency

Tel: 020 3080 6000

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Batten, David, Medicines and Healthcare products Regulatory Agency

Dear Ms Bloor

Thank you for your e-mail of 11 June below asking under the Freedom of Information Act for the type of information held by MHRA on CE marked medical devices and approvals.

All but the lowest risk medical devices are CE marked by the manufacturer on the basis of conformity assessment certification from a notified body who are independent assessment organisations designated as competent to undertake this function by a member states competent authority such as MHRA in the UK. CE marking denotes that the device meets the safety, quality and performance requirements laid down in the EC Medical Devices Directive and can be placed freely on the market in any member state without further restriction. Manufacturers of the lowest risk devices can CE mark them on the basis of a self-declaration of compliance with the requirements of the Directive and registration with a member state but in neither instance is the Competent Authority directly involved in the CE marking of a device before it goes on the market. A list of UK based manufacturers of low risk devices who have registered with MHRA is published on the MHRA website but otherwise MHRA do not routinely collect information on the CE marked devices placed on the market or used in the UK or the data used by the manufacturer to demonstrate compliance with the requirements of the Directive and Regulations.

MHRA has a mainly post market surveillance role including enforcement and has the power to obtain information from manufacturers in connection with any investigation of non-compliance or faulty device incidents reported to it after the device is on the market. Such information is assessed against trends and the requirements of the Directive and appropriate action taken either to warn users and/or to take enforcement action against the manufacturer. In addition UK notified bodies are regularly audited by MHRA and their assessment audits of manufacturers witnessed to ensure that they are carrying out their functions correctly and if necessary designation can be removed. Notified bodies themselves though are not public authorities and consequently they do not fall within the ambit of the Freedom of Information Act.

Without prejudice to national provisions and practices on medical confidentiality any specific information obtained for regulatory purposes by MHRA and notified bodies for conformity assessment purposes (apart from the information contained in certificates issued, modified, supplemented, suspended or withdrawn) is required to be kept confidential between the parties concerned under Article 20 of the Directive and is exempted from disclosure to third parties under section 44 of the Freedom of Information Act 2000 (FOIA). Under Section 44, information can be withheld, where a statutory bar prohibits disclosure under any rule or enactment, or is deemed incompatible with a community obligation. Disclosing this information would not be appropriate because Article 20 constitutes a statutory bar and it would breach MHRAs obligations of confidentiality to disclose it. Since this obligation stems from a community directive, it is exempt from disclosure under FOIA. Section 44 is an absolute exemption, and consequently is not subject to any public interest balance.

Member states obligations in relation to providing mutual information and disseminating warnings and those of persons concerned providing information under criminal law are not affected by Article 20.

I hope this is helpful. If you are not satisfied with the reply we have given you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue this option please write quoting the reference number above to:

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Medicines and Healthcare products Regulatory Agency,
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London, SW1W 9SZ.

After that if you remain dissatisfied you may ask the Information Commissioner to make a decision whether or not we have interpreted the Freedom of Information Act correctly. They can be contacted at:

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Cheshire SK9 5AF

Yours sincerely

David Batten

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